AMP files lawsuit against FDA to challenge lab-developed test final rule
September 2024—The Association for Molecular Pathology and pathologist Michael Laposata, MD, PhD, announced on Aug. 19 the filing of a lawsuit challenging the Food and Drug Administration rule that regulates laboratory-developed test procedures as medical devices under the Federal Food, Drug, and Cosmetic Act.
The lawsuit was filed in the U.S. District Court for the Southern District of Texas against the FDA; Robert M. Califf, MD, in his official capacity as commissioner of food and drugs; the U.S. Department of Health and Human Services; and Xavier Becerra, in his official capacity as secretary of HHS.
“AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country,” Maria Arcila, MD, AMP president, said in a statement. “We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine.” She added, “AMP will continue working with key stakeholders to develop a more effective and efficient legislative framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies.”
The AMP says it has long maintained that the best approach to ensuring the continued development of accurate and reliable LDT procedures and for the correct use, precise interpretation, and proper application of molecular test results is through modernizing the current CLIA regulations.
CAP webinar series on lab-developed tests
The CAP is offering a six-part webinar series on understanding and preparing for the impact of the FDA’s laboratory-developed test final rule.
The first webinar took place Sept. 18 and will be available shortly after that date online. Its focus is the FDA’s risk classification systems and the differences in FDA and CLIA classifications, the requirements under the FDA risk categories, and the activities included in the FDA’s general and special controls. CAP president Donald Karcher, MD, cites examples of common tests and explains how the requirements will apply.
The schedule for the remaining five webinars and the topics are as follows:
- Nov. 7, 2024 (noon to 1 PM CT): Adverse Event Reporting Requirement.
- Jan. 9, 2025 (noon to 1 PM CT): Corrective Action and Removal Reporting.
- March 20, 2025 (noon to 1 PM CT): Rules for Quality System Complaint Processes.
- May 8, 2025 (noon to 1 PM CT): How Enforcement Discretion Categories and Modification Rules Apply to Your LDTs.
- July 10, 2025 (noon to 1 PM CT): Navigating the FDA’s LDT Oversight Requirements During a Public Health Emergency.
To register for the webinars, go to: https://www.cap.org/calendar/webinars/understand-and-prepare-for-the-impact-of-the-fdas-ldt-final-rule.